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Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

Primary Purpose

Iron Deficiency, Neonatal Hyperbilirubinemia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Timing of clamping the umbilical cord
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency focused on measuring Umbilical cord, cord clamping, iron, Ferritin, newborn, jaundice, infant, development, infections

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • non-smoking mother
  • healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone),
  • normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection)
  • single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days)
  • expected vaginal delivery with cephalic presentation
  • mother should be able to master Swedish well enough to participate in the study
  • mother should live close enough to the hospital to be ready to return for follow up after four months.

Exclusion Criteria:

  • Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures

Sites / Locations

  • Länsjukhuset i Halmstad

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early cord clamping (ECC)

Delayed cord clamping (DCC)

Arm Description

Early cord clamping consisted of early (< 10 s) clamping of the umbilical cord and obtaining blood gas samples after clamping.

Delayed cord clamping consisted of delayed (> 180 s) clamping of the umbilical cord and obtaining blood gas samples before clamping (within 30 seconds).

Outcomes

Primary Outcome Measures

Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status

Secondary Outcome Measures

Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status.
Are the rates of successful umbilical arterial samples equal between the groups?
Arterial blood samples are obtained with different methods between groups: in the early clamped group samples are taken from the placental part of the clamped cord, in the delayed clamped group samples are taken before clamping in the still pulsating cord. At the same time umbilical venous samples are obtained. A arterial blood sample is assessed as successful when ph < 0.2 and partial pressure of carbon dioxide (pCO2) > 0.5 kPa compared to the venous sample.
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 4-month questionnaire will be assessed.
Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?
After birth of their child, until four months of age parents fill out a form where they daily note if their infant has intestinal or respiratory symptoms, as well as if the infant has middle ear infection, has visited a doctor, has had an antibiotic prescription or has been admitted into a hospital.
Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?
Reticulocyte hemoglobin (RetHE) is a novel measure suggested to describe iron status. Ret HE will be compared to other indicators of iron stores: mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), serum ferritin, transferrin saturation and soluble transferrin receptors
Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?
Anemia defined as hemoglobin < 145 g/L, polycythemia defined as hematocrit > 0.65.
Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?
Measuring time to placental abortion, post partal hemorrhage and mothers post partum need for blood transfusion
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 12-month questionnaire will be assessed.
Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?
Blood samples for metabolic screening are routinely taken as soon as possible after 2 days (48 hours) of age. At the same time samples for Immunoglobulin G is obtained.
Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?
Reticulocyte hemoglobin (RetHE) is a novel measure suggested to describe iron status. Ret HE will be compared to other indicators of iron stores: mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), serum ferritin, transferrin saturation and soluble transferrin receptors
Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?
Midwives observes the newborn infant at 1 hour and 6 hours of age and note presence of tachypnea (> 60 breaths/minute), grunting, nostril flaring and or retractions between or under the ribs.

Full Information

First Posted
October 13, 2010
Last Updated
August 19, 2014
Sponsor
Uppsala University
Collaborators
Umeå University, Halmstad County Hospital, County Council of Halland, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01245296
Brief Title
Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
Official Title
Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Umeå University, Halmstad County Hospital, County Council of Halland, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight. The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants. The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Neonatal Hyperbilirubinemia
Keywords
Umbilical cord, cord clamping, iron, Ferritin, newborn, jaundice, infant, development, infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early cord clamping (ECC)
Arm Type
Other
Arm Description
Early cord clamping consisted of early (< 10 s) clamping of the umbilical cord and obtaining blood gas samples after clamping.
Arm Title
Delayed cord clamping (DCC)
Arm Type
Other
Arm Description
Delayed cord clamping consisted of delayed (> 180 s) clamping of the umbilical cord and obtaining blood gas samples before clamping (within 30 seconds).
Intervention Type
Procedure
Intervention Name(s)
Timing of clamping the umbilical cord
Other Intervention Name(s)
Delayed cord clamping is also called Late cord claming
Intervention Description
The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
Primary Outcome Measure Information:
Title
Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
Description
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status
Time Frame
4 months of age (plus or minus three weeks)
Secondary Outcome Measure Information:
Title
Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?
Description
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status.
Time Frame
12 months of age (plus or minus one month)
Title
Are the rates of successful umbilical arterial samples equal between the groups?
Description
Arterial blood samples are obtained with different methods between groups: in the early clamped group samples are taken from the placental part of the clamped cord, in the delayed clamped group samples are taken before clamping in the still pulsating cord. At the same time umbilical venous samples are obtained. A arterial blood sample is assessed as successful when ph < 0.2 and partial pressure of carbon dioxide (pCO2) > 0.5 kPa compared to the venous sample.
Time Frame
Immediately after birth (within 30 seconds)
Title
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?
Description
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 4-month questionnaire will be assessed.
Time Frame
4 months of age (plus or minus three weeks)
Title
Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?
Description
After birth of their child, until four months of age parents fill out a form where they daily note if their infant has intestinal or respiratory symptoms, as well as if the infant has middle ear infection, has visited a doctor, has had an antibiotic prescription or has been admitted into a hospital.
Time Frame
4 months of age (plus or minus three weeks)
Title
Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?
Description
Reticulocyte hemoglobin (RetHE) is a novel measure suggested to describe iron status. Ret HE will be compared to other indicators of iron stores: mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), serum ferritin, transferrin saturation and soluble transferrin receptors
Time Frame
Mean 2 to 3 days of age (within 48-96 hours after birth)
Title
Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?
Description
Anemia defined as hemoglobin < 145 g/L, polycythemia defined as hematocrit > 0.65.
Time Frame
Within 7 days after birth
Title
Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?
Description
Measuring time to placental abortion, post partal hemorrhage and mothers post partum need for blood transfusion
Time Frame
After giving birth until discharge from maternity ward
Title
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?
Description
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 12-month questionnaire will be assessed.
Time Frame
12 months of age (plus or minus one month)
Title
Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?
Description
Blood samples for metabolic screening are routinely taken as soon as possible after 2 days (48 hours) of age. At the same time samples for Immunoglobulin G is obtained.
Time Frame
Mean 2 to 3 days of age (within 48-96 hours after birth)
Title
Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?
Description
Reticulocyte hemoglobin (RetHE) is a novel measure suggested to describe iron status. Ret HE will be compared to other indicators of iron stores: mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), serum ferritin, transferrin saturation and soluble transferrin receptors
Time Frame
12 months of age (plus or minus one month)
Title
Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?
Description
Midwives observes the newborn infant at 1 hour and 6 hours of age and note presence of tachypnea (> 60 breaths/minute), grunting, nostril flaring and or retractions between or under the ribs.
Time Frame
Within 6 hours after birth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-smoking mother healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone), normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days) expected vaginal delivery with cephalic presentation mother should be able to master Swedish well enough to participate in the study mother should live close enough to the hospital to be ready to return for follow up after four months. Exclusion Criteria: Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Andersson, M.D.
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magnus Domellöf, MD, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Länsjukhuset i Halmstad
City
Halmstad
State/Province
Halland
ZIP/Postal Code
30187
Country
Sweden

12. IPD Sharing Statement

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Results Reference
derived

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Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

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